Covid-19 vaccines: Fact sheets in India warn against use in immuno-compromised

Fact sheets for both the Coronavirus disease (Covid-19) vaccines that are approved for use in India have warned against use of these vaccines in immuno-compromised persons or in persons taking medicines that can affect the immune system. A fact sheet released by the Union health ministry doesn't specifically mention these conditions as contraindications for Covid-19 vaccines.

"You should not get the Bharat Biotech Covid-19 vaccine, Covaxin, if you are immune-compromised, or are on a medicine that affects your medicine, have any history of allergies, have fever, have a bleeding disorder or are on a blood thinner, are pregnant or breastfeeding, have received another Covid-19 vaccine, or any other serious health related issues, as determined by the vaccinator/officer supervising vaccination," says Bharat Biotech's fact sheet on Covaxin that the company has put out in compliance with the national drugs controller's regulatory approval conditions under clinical trial mode.

Serum Institute of India (SII) that is locally manufacturing Oxford-AstraZeneca Covid-19 vaccine that it calls Covishield has also put out a fact sheet enlisting contraindications and precautions that need to be taken while administering the vaccine.

"What should you mention to your health care provider before you get Covishield vaccine? Tell the health care provider about all your medical conditions, including: if you are immunocompromised or are on a medicine that affects your immune system, ever had a severe allergic reaction (anaphylaxis) after any drug, food, any vaccine, or any ingredients of Covishield vaccine, have fever, have a bleeding disorder or are on a blood thinner, are pregnant or plan to become pregnant, are breast feeding or received another Covid-19 vaccine. You should consult your health care provider before deciding to take the vaccine…," says SII fact sheet on Covishield.

The Covaxin fact sheet was released last week, and for Covishield, SII released the fact sheet earlier this month.

The health ministry's guidance document for States on precautions and contraindications for Covid-19 vaccine released two days before the launch of Covid-19 vaccination drive on January 16, however, did not mention a recipient's immune status as a contraindication for taking these vaccines.

"Following conditions are not contraindicated for Covid vaccines: immune-deficiency, HIV, patients on immune-suppression due to any condition (the response to the Covid-19 vaccines may be less in these individuals); history of chronic diseases and morbidities (cardiac, neurological, pulmonary, metabolic, renal, malignancies); Persons with a past history of Sars-CoV-2 infection (sero-positivity), and or RT-PCR positive illness," read the health ministry document sent to states by Manohar Agnani, additional secretary (health).

Agnani's letter to states also mentioned certain conditions for which giving the vaccine should be deferred by four to eight weeks after recovery, and that include having active symptoms of Covid-19 infection, hospitalized patients who were given convalescent plasma therapy or monoclonal antibodies, and those who are acutely unwell and hospitalized (with or without intensive care) due to any illnesses.

"Special precautions need to be taken while giving the vaccine to persons with history of any bleeding or coagulation disorder such as clotting factor deficiency, coagulopathy or platelet disorder," it said.

India has so far seen 0.15% adverse events following immunisation (AEFI) since it launched the Covid-19 vaccination drive on Saturday, January 16.

Experts say it is a minuscule number in comparison to the benefits that vaccinating country's high-risk population will achieve.

"Acceptable level of AEFI would ideally be zero, but that is not the case. I think it is around 0.2% and yet we are focussing on that and not the 99.8% benefit," said Dr Shahid Jameel, former CEO of Wellcome Trust/DBT India Alliance.